What side effects are associated with this type of intervention?

Common treatments for cancer prevention, such as green tea (EGCG), butyric acid, nicotinamide, and calcium glucarate, generally have mild side effects. Green tea can cause gastrointestinal issues, liver toxicity in high doses, and caffeine-related side effects like insomnia and nervousness. Butyric acid may cause gastrointestinal discomfort. Nicotinamide is usually well-tolerated but can cause nausea and headaches. Calcium glucarate is also well-tolerated but may cause mild gastrointestinal disturbances. Prolonged nightly fasting, similar to the PROFAST intervention, can lead to side effects such as hunger, irritability, fatigue, and potential nutrient deficiencies if not properly managed.

What prior FDA approvals exist?

FDA approvals for cancer prevention have included various pharmacologic interventions, though specific approvals for treatments inducing metabolic changes through fasting are not well-documented. Notable FDA-approved drugs for cancer prevention include aspirin, which has shown efficacy in reducing the risk of recurrent adenomas in colorectal cancer, and other agents like tamoxifen and raloxifene for breast cancer prevention. These treatments focus on reducing cancer risk through different mechanisms, such as anti-inflammatory effects and hormone modulation, rather than metabolic changes induced by fasting.

What other types of research exist?

Promising alternatives to prolonged nightly fasting for cancer prevention include: 1) Dietary carbohydrate restriction combined with supplementation of AMPK-activating phytochemicals, which has shown potential in preclinical models. 2) Increased intake of dietary fiber, particularly cereal fiber, which has been associated with lower cancer-specific and all-cause mortality in colorectal cancer patients. 3) Diets rich in nuts, which have been linked to reduced rates of cancer recurrence and improved survival in patients with stage III colon cancer. 4) Adopting a Mediterranean diet, which has been associated with a reduction in the incidence of type 2 diabetes and cardiovascular disease, both of which are risk factors for cancer. These alternatives should be discussed with a healthcare provider to tailor the approach to individual patient needs.

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Fasting for Multiple Myeloma Prevention (PROFAST Trial)

N/A

Recruiting

Led By Catherine Marinac, Ph.D

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Must not have

Diagnosis of overt MM or WM

Patients diagnosed with another malignancy requiring active therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4-months

Awards & highlights

Summary

This trial tests if not eating for a certain number of hours each night can help overweight and obese people with certain pre-cancerous conditions avoid developing blood cancer. The study involves a small group of people who will either follow the fasting plan or receive healthy living tips. Not eating for a set period each night is a new approach for weight loss that may have additional health benefits.

Who is the study for?

This trial is for overweight or obese adults with precursor blood cancers like MGUS, SMM, or SWM who fast less than 14 hours at night. Participants must be comfortable using a cell phone to send texts and have no active cancer treatments, diabetes without doctor's consent, night shift work, eating disorders affecting nighttime eating, or use of weight loss meds.

What is being tested?

The study tests if not eating for extended periods at night (PROFAST) can help prevent blood cancer in individuals at risk. It randomly assigns participants to either the PROFAST group that practices prolonged fasting nightly for four months or a control group that follows a healthy lifestyle without specific fasting instructions.

What are the potential side effects?

Potential side effects are not specified but may include hunger pangs, irritability due to fasting, potential hypoglycemia especially in those predisposed (like diabetics), and possible changes in sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with multiple myeloma or Waldenström's macroglobulinemia.

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I am currently being treated for another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in body composition

Secondary study objectives

Body Weight Changes

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PROLONGED FASTING INTERVENTIONExperimental Treatment1 Intervention

The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study.

Group II: EDUCATION CONTROLActive Control1 Intervention

For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer prevention treatments often focus on dietary and lifestyle modifications that influence metabolic pathways. Prolonged nightly fasting, as studied in the PROFAST trial, aims to reduce cancer risk by improving insulin sensitivity and reducing hyperinsulinemia, which are linked to cancer progression. This fasting approach may also decrease oxidative stress and inflammation, both of which are associated with cancer development. Additionally, dietary fiber intake, reduced alcohol and tobacco use, and maintaining a healthy weight through balanced nutrition and physical activity are crucial. These interventions collectively help in modulating metabolic and hormonal environments, thereby reducing the risk of cancer recurrence and improving overall survival rates for cancer prevention patients.